Pharmaceutical Regulatory Affairs in Mexico

Getting your drugs approved by COFEPRIS isn’t always simple — especially with local rules shifting often. That’s where our regulatory affairs team comes in.

Services We Offer

Regulatory Affairs Consultant for Pharmaceuticals in Mexico

Bringing a pharmaceutical product into Mexico isn’t just about getting paperwork done — it’s about understanding how COFEPRIS works on the ground. The rules aren’t always obvious, and the approval process can take time. Language and local regulatory nuances add another layer.

If you’re not familiar with the system, you can easily hit delays. That’s where local support matters.

At Artixio, we work with pharmaceutical companies who want a smoother path to registration. Whether it’s a new product or a license update, we handle the details — so you can focus on the bigger picture.

Pharma Regulatory Authorities in Mexico:

Pharmaceuticals in Mexico are regulated by COFEPRIS, a division of the Ministry of Health. They don’t just review applications — they control everything from clinical trial oversight to product approvals, plant inspections, import permits, advertising, and even post-market safety.

For most companies outside Mexico, COFEPRIS can feel like a black box. The process doesn’t follow international (ICH) standards. The document formats are different, and many supporting papers need to be legally verified or officially certified. In most cases, you’ll also need a local legal representative — COFEPRIS won’t accept submissions directly from foreign companies unless you’re already registered in Mexico.

Artixio acts as that bridge and become your local partner — the kind of pharmaceutical regulatory affairs company in Mexico that helps you cut through red tape and move forward with clarity.

We work directly with COFEPRIS reviewers, clarify requirements early, and follow up at each stage so you’re not left waiting without updates. For products manufactured abroad, we also help in getting GMP certificates recognized — something that often delays applications if not handled proactively.

Whether it’s a fast-track approval for a priority medicine, or a standard dossier for a generic or biologic, we don’t just translate your documents — we translate the system for you.

If you’re planning to register your pharma product in Mexico, we can represent you locally, manage coordination with COFEPRIS, and keep timelines predictable.

Why Artixio for Pharmaceutical Regulatory Affairs in Mexico

FAQs

Is Artixio a licensed pharmaceutical regulatory affairs company in Mexico?

Yes, Artixio works with authorized local legal representatives and industry experts in Mexico. We help clients meet all COFEPRIS requirements efficiently, even if they don’t have a local entity. Our experience covers Rx, OTC, generics, and biologics.

How do you coordinate with COFEPRIS for regulatory approvals?

As a pharmaceutical regulatory affairs consultancy in Mexico, we coordinate with licensed third-party legal representatives and ensure that all submissions meet COFEPRIS standards. We manage timelines, documentation, and follow-ups on behalf of our clients.

Can you support pharmaceutical companies outside of Mexico?

Absolutely. We specialize in supporting international pharma companies looking to enter the Mexican market. Whether you’re based in the US, EU, or Asia, our pharma regulatory consultants in Mexico ensure compliance without the need to set up a local office.

Do you handle regulatory affairs for drug registration in Mexico from start to finish?

Yes, we do. We usually begin by reviewing your product and identifying what COFEPRIS will expect. From there, we help prepare the required documents, coordinate with local representatives, and manage the submission. If COFEPRIS raises any questions, we work with you to respond quickly. You’ll have our support all the way through to final approval.